KR20230070474A - Blood collection devices, systems and methods to facilitate air priming - Google Patents

Abstract

A blood collection device for priming a blood flow path may include a cannula, a holder and an elastomeric sleeve. The cannula may include a proximal end, a distal end and a lumen extending along a longitudinal axis therebetween. The cannula may include a slot that allows a user to visualize the blood flow path through the cannula. The holder may include a channel configured to be aligned with the longitudinal axis to retain the shaft of the cannula. The holder may further include a visual check window corresponding to the slot of the cannula. An elastomeric sleeve may be coupled to the holder to enclose the proximal end of the cannula. A priming opening for priming the blood flow path may be disposed between the elastomer sleeve and the holder.

Description

Blood collection devices, systems and methods to facilitate air priming

[0001] This application claims priority to U.S. Provisional Application Serial No. 63/081,091, filed September 21, 2020, entitled "Blood Collection Apparatus, System, and Method for Facilitating Air Priming," the entire disclosure of which is incorporated herein by reference.

Intravenous catheters are commonly used for various infusion treatments. For example, intravenous catheters can be used to inject liquids such as normal saline, various medications, and total parenteral nutrition into the patient. A venous catheter may be used to draw the patient's blood.

Common types of venous catheters are peripheral IV catheters ("PIVC"), peripherally inserted central catheters ("PICC"), and midline catheters. A venous catheter may include an "on a needle" catheter that may be mounted over a needle with a sharp distal tip. A sharp distal tip can be used to pierce the patient's skin and blood vessels. When an intravenous catheter is inserted into a vascular structure, the vascular structure can be punctured with a needle. The needle and intravenous catheter are generally inserted at a shallow angle into the patient's vasculature through the skin with the bevel of the needle facing up and away from the patient's skin.

To confirm proper placement of the introducer needle and/or intravenous catheter in the vasculature, the user typically checks for a flashback of blood visible to the user. In some cases, the introducer needle may include a notch disposed toward the distal end of the introducer needle, and in response to the distal end of the introducer needle being placed within the vasculature, blood is drawn proximal through the needle lumen. After exiting the needle lumen through the notch, it moves proximally between the outer surface of the introducer needle and the inner surface of the venous catheter.

Thus, when the venous catheter is at least partially transparent, the user can visualize a small amount of blood "flashback" to confirm the position of the venous catheter within the vascular structure. In the presence of vascular access indicators such as flashbacks, venous catheters can be successfully placed. You can also use flashback to perform air priming, which expels air out of the flow path. Once placement of the introducer needle within the vessel is confirmed, the user can temporarily block flow in the vessel and withdraw the introducer needle, leaving the venous catheter in place for subsequent blood withdrawal and/or fluid infusion.

For blood collection, a blood collection tube may be attached to the catheter through a connector. For example, the VACUTAINER™ blood collection tube contains a sterile glass or plastic test tube with a rubber stopper that creates a vacuum inside the tube to facilitate drawing a predetermined amount of blood from the patient. A double-ended needle may be used to draw blood from the patient. The proximal end of the needle may be placed inside the holder and the distal end of the needle may be inserted into the patient's catheter or vein. When the VACUTAINER™ blood collection tube is inserted into the holder, the rubber stopper can be punctured by the proximal end of the needle, and vacuum in the tube can draw blood through the needle and into the tube. The filled tube can then be removed and another tube inserted and filled in the same way.

The claimed subject matter is not limited to embodiments that solve any disadvantages or operate only in such circumstances. Rather, this background is provided to describe one example technology area in which some implementations disclosed herein may be practiced.

The present invention relates generally to blood collection devices, systems and methods for priming blood flow pathways. In some embodiments, a blood collection device may include a cannula, a holder, and an elastomeric sleeve. In some embodiments, a cannula may include a proximal end, a distal end and a lumen extending along a longitudinal axis therebetween. Some embodiments of the cannula may include a slot that allows the user to visualize the blood flow path through the cannula.

In some embodiments, the holder can include a proximal end, a distal end and a channel extending therebetween. Some embodiments of the channel may be configured to be aligned with the longitudinal axis to support the shaft of the cannula. In some embodiments, the holder may include a visual check window corresponding to the slot of the cannula.

In some embodiments, an elastomeric sleeve can be coupled to the holder and can surround the proximal end of the cannula. In some embodiments, a priming opening for priming the blood flow path may be disposed between the elastomeric sleeve and the holder. In some embodiments, the priming opening may be automatically sealed in response to the blood collection tube being coupled to the holder. In some embodiments, the elastomeric sleeve can automatically seal the priming opening.

In some embodiments, the holder can be configured to couple to the blood collection tube such that the proximal end of the cannula and the elastomeric sleeve extend through the distal end of the blood collection tube. In some embodiments, the holder may be configured to engage a needleless connector. In some embodiments, the holder may include a contact interface for physical manipulation of the cannula.

In some embodiments, the holder can include a protrusion extending from the proximal end of the holder along a longitudinal axis. Some embodiments of the protrusion may include at least a portion of the channel. In some embodiments, the protrusion may include the priming opening.

Some embodiments of the blood collection system may include a Y adapter that includes a distal end, a first proximal port and a second proximal port. In some embodiments, the blood collection system can further include a blood collection device coupled to the first proximal port.

In some embodiments, the blood collection device may include a body including a distal end, a proximal end, and a longitudinal axis extending therebetween. In some embodiments, a diaphragm may be disposed within the body. In some embodiments, a cannula having a distal end and a pointed proximal end may extend through a septum. In some embodiments, an elastomeric sleeve may be coupled to the body to cover the sharp proximal end of the cannula.

In some embodiments, an air tube may extend through the septum. In some embodiments, the air film may be disposed proximate to the air tube. Some embodiments of the air priming path may include an air tube and an air membrane. In some embodiments, the blood collection path separate from the air priming path includes a cannula.

In some embodiments, the distal end of the body includes a male luer adapter, and the cannula may extend through the distal end of the body. In some embodiments, the body may include an extension between the diaphragm and the elastomeric sleeve. Some embodiments of the extension may be configured to be supported by a user. In some embodiments, the air film may be disposed within the extension.

In some embodiments, the elastomeric sleeve may automatically seal the air priming path in response to the blood collection tube being coupled to the body. In some embodiments, the blood collection system can further include a seal ring disposed within the first proximal port such that the cannula extends through the seal ring. In some embodiments, the seal ring may be disposed at a distal end of the first proximal port. In some embodiments, the seal ring may be disposed adjacent to the diaphragm.

In some embodiments, an air tube may include a plurality of channels. Some embodiments of the blood collection pathway may include a first channel and some embodiments of the air priming pathway may include a second channel. In some embodiments, the air priming path may include an air rod to replace the air tube and air membrane. Some embodiments of an air rod may include a porous material to allow air to pass through and to keep liquid out. In some embodiments, the air rod may be integrated with the body of the blood collection device.

It should be understood that both the foregoing general description and the following detailed description are illustrative and explanatory, and are not intended to limit the invention as claimed. It should be understood that the various embodiments are not limited to the arrangements and tooling shown in the drawings. It is also to be understood that the above embodiments may be combined, or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the present invention, unless specifically claimed. Accordingly, the following detailed description should not be taken in a limiting sense.

Exemplary embodiments will be described with additional specificity and detail using the accompanying drawings.
1A is a top perspective view of a blood collection system implementing a Y adapter in accordance with some embodiments;
1B is a top perspective view of another exemplary blood collection system implementing a Y adapter in accordance with some embodiments;
2A is a side perspective view of a blood collection device used in conjunction with a Y adapter according to some embodiments;
2B is another perspective side view of the blood collection device of FIG. 2A used in conjunction with the Y-adapter of FIG. 2A in accordance with some embodiments;
2C is a top perspective view of the blood collection device of FIG. 2A used in conjunction with the Y-adapter of FIG. 2A in accordance with some embodiments;
3 is a perspective view of a plurality of blood collection devices in accordance with some embodiments;
4A is a perspective view of one of the blood collection devices of FIG. 3 integrated with an exemplary catheter in accordance with some embodiments;
4B is a perspective view of one of the blood collection devices of FIG. 3 integrated with an exemplary catheter assembly in accordance with some embodiments;
4C is a top cross-sectional view of one of the blood collection devices of FIG. 3 integrated with an exemplary catheter adapter in accordance with some embodiments;
5 is a cross-sectional view of an exemplary blood collection device in accordance with some embodiments;
6 is a perspective view of a blood sampling device according to some embodiments of FIG. 5;
7 is a cross-sectional view of another exemplary blood collection device in accordance with some embodiments;
8 is a perspective view of a blood sampling device according to some embodiments of FIG. 7;
9A is a perspective view of an exemplary holder in accordance with some embodiments;
9B is a cross-sectional view of another exemplary catheter system in accordance with some embodiments;
10A is a perspective view of another exemplary holder in accordance with some embodiments;
10B is a perspective view of an exemplary blood collection device including the holder of FIG. 10A in accordance with some embodiments;
11A is a perspective view of another exemplary holder in accordance with some embodiments;
11B is a perspective view of an exemplary blood collection device including the holder of FIG. 11A in accordance with some embodiments;
12A is a perspective view of another exemplary holder in accordance with some embodiments;
12B is a perspective view of an exemplary blood collection device including the holder of FIG. 12A in accordance with some embodiments;
13A is a perspective view of another exemplary holder in accordance with some embodiments;
13B is a perspective view of an exemplary blood collection device including the holder of FIG. 13A in accordance with some embodiments;
14 is a cutaway perspective view of an exemplary blood collection device integrated with a Y-adapter in accordance with some embodiments;
15 is a cross-sectional perspective view of the exemplary blood collection device of FIG. 14 in accordance with some embodiments;
16A is a perspective view of an exemplary seal ring in accordance with some embodiments;
16B is a perspective view of another exemplary seal ring in accordance with some embodiments;
17A is a cutaway perspective view of the exemplary blood collection device showing the seal ring of FIG. 16B;
17B is a cutaway perspective view of another exemplary blood collection device showing the seal ring of FIG. 16A;
18A is a cutaway perspective view of an exemplary blood collection device showing an air duct with a plurality of channels, in accordance with some embodiments;
18B is an enlarged view of a portion of the blood collection device and air tube of FIG. 18A, in accordance with some embodiments;
19A is a cutaway perspective view of an exemplary blood collection device showing an exemplary air tube, in accordance with some embodiments;
19B is a cutaway perspective view of an exemplary blood collection device showing an exemplary air rod, in accordance with some embodiments.

All examples and conditional language cited herein are for pedagogical purposes to assist the reader in understanding the invention and the concepts that the inventor contributed to advance the art, and are not limited to these specifically cited examples and conditions. should be interpreted Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions and modifications may be made without departing from the spirit and scope of the present invention.

Referring to FIGS. 1A and 1B , in some embodiments, blood collection system 10 may communicate with catheter assembly 2 through adapter 14 , such as a Y adapter. In some embodiments, catheter 4 of catheter assembly 2 may be placed into a blood vessel of a patient for infusion of saline or medication and withdrawal of blood.

In some embodiments, a medical liquid or saline solution may be injected through the side port 6 of the adapter 14 to purge air from the flow path prior to inserting the catheter 4 into the blood vessel. However, when the vacuum blood collection tube 50 is connected to the adapter 14, the medical liquid or saline is mixed with the blood sample, diluting the blood sample and causing an inaccurate diagnosis. Some clinicians use blood flashback to remove air from the flow path. However, blood may coagulate inside the adapter 14 after blood collection if the air priming procedure is not properly or properly performed. Embodiments disclosed herein solve these and other problems.

Some embodiments of the blood collection system 10 may include an adapter 14 that includes a distal port 58 , a first proximal port opening 60 and a second proximal port 62 . In some embodiments, adapter 14 may include a Y adapter, a T adapter, or other suitable adapter 14 . In some embodiments, blood collection device 12 may be coupled to first proximal port 60 via needleless adapter 54, such as, for example, a luer adapter.

Referring to FIG. 1A , in some embodiments, blood collection device 12 may include a cannula 22 having a slot 32 to allow a user to visualize the blood flow path through cannula 22. . In some embodiments, shaft 42 of cannula 22 may be held by holder 34 . In some embodiments, cannula 22 may be made of steel or other suitable biocompatible material. In some embodiments, holder 34 may be made of a polymer, rubber or other suitable material. Some embodiments of holder 34 may include a visual inspection window 44 corresponding to slot 32 of cannula 22 .

In some embodiments, the elastomeric sleeve 46 may be coupled to the holder 34 and encircle the proximal end 24 of the cannula 22 . In some embodiments, a priming aperture 48 may be disposed between the elastomeric sleeve 46 and the holder 34 to prime the blood flow path. In some embodiments, priming opening 48 may automatically seal upon connection of blood collection tube 50 to holder 34 .

Referring to FIG. 1B , in some embodiments, blood collection device 12 may include a body 64 having a septum 72 disposed therein. In some embodiments, cannula 22 having a distal end 76 and a pointed proximal end 78 may extend through septum 72 . In some embodiments, elastomeric sleeve 46 may be coupled to body 64 to cover sharp proximal end 78 of cannula 22 . In some embodiments, the air priming path may be separate from the blood collection path for priming the blood collection device 12 . In some embodiments, the elastomeric sleeve 46 may automatically seal the air priming path upon coupling of the blood collection tube 50 to the body 64 .

Referring to Figures 2a, 2b and 2c, some prior art blood collection devices 12 have a risk of contamination by residual blood 98 inside the adapter 14 and/or inside the needleless adapter 54 after blood collection. there is In practice, if the air priming procedure is not performed properly or properly, residual blood 98 may contaminate the infusion or blood sample obtained after the air priming procedure.

As shown in FIGS. 2A and 2B, in the conventional blood sampling device 12, along the inner wall of the adapter 14, typically, the junction of the first proximal port 60 and the second proximal port 62 or It is common for residual blood 98 to accumulate in the port 58 near or distal thereto. It is also common for residual blood 98 to accumulate along or within the threads or crevices of the needleless adapter 54 or the surface of the cap 100 attached to the needleless adapter 54 . In some cases, blood 98 may clot within adapter 14 and/or an attached catheter or tube, as shown in FIG. 2C. This can contaminate the infusion or blood sample obtained after the air priming procedure as well as obstruct the fluid pathway.

In other cases, the conventional blood collection device 12 may not allow the user to visualize the blood flashback unless the blood collection tube 50 is attached. In other cases, some prior art blood collection devices 12 may not allow the air priming procedure to be performed at all, which may adversely affect the volume of the first sample.

Referring to FIG. 3 , some embodiments of the blood collection device 12 disclosed and claimed herein may address the risks and disadvantages of the prior art set of devices. As shown in FIG. 3 , in some embodiments, blood collection device 12 may include cannula 22 , holder 34 and elastomeric sleeve 46 . In some embodiments, cannula 22 may include a proximal end 24 , a distal end 26 and a lumen 20 therebetween. In some embodiments, lumen 20 may extend along longitudinal axis 30 .

Some embodiments of holder 34 may allow a user to hold and physically manipulate cannula 22 . In some embodiments, holder 34 may include a contact interface 56 for physical manipulation of cannula 22 . In some embodiments, holder 34 may include a proximal end 36, a distal end 38 and a channel 40 extending therebetween. Some embodiments of channel 40 may support shaft 42 of cannula 22 .

Some embodiments of cannula 52 may include a slot 32 that allows a user to visualize the blood flow path through cannula 22 . Likewise, some embodiments of holder 34 may include a visual inspection window 44 corresponding to slot 32 of cannula 22 . Some embodiments of the blood collection device 12 may be configured such that the slot 32 is aligned with the visual check window 454, allowing a user to visualize the blood flow path or blood flashback through the blood collection device 12. .

In some embodiments, an elastomeric sleeve 46 may be coupled to the holder 34 to surround the proximal end 24 of the cannula 22 . Some embodiments of the elastomeric sleeve 46 may include rubber or other suitable elastomeric material. In some embodiments, the elastomeric sleeve 46 can be biocompatible and substantially liquid impermeable.

In some embodiments, one or more priming openings 48 may be disposed between the elastomeric sleeve 46 and the holder 34 and proximate the interface therebetween. In some embodiments, the elastomeric sleeve 46 may act as a trigger for priming and blood sampling. For example, upon insertion of blood collection device 12 into a blood vessel of a patient, elastomeric sleeve 46 may prime air present in the blood flow path through priming aperture 48 . Some embodiments of the priming opening 48 may include a gap opening 54 and a priming slot 55 . In some embodiments, the blood's high surface tension and high viscosity allow blood present inside the blood flow path to be retained by the elastomeric sleeve 46 instead of leaking through the priming opening 48 to the environment.

In some embodiments, connecting the blood collection tube 50 to the holder 34 may pressurize the elastomeric sleeve 46 to securely seal the elastomeric sleeve 46 at the priming opening 48 . In some embodiments, blood collection device 12 may automatically start drawing a blood sample. The blood collection device 12 may automatically stop blood collection as the blood collection tube 50 is separated from the holder 34 . Similarly, some embodiments of the blood collection device 12 may automatically perform an air priming procedure prior to sample collection and may automatically stop the air priming procedure when the blood collection tube 50 is attached to the blood collection device 12 .

Referring to FIGS. 4A-4C , in some embodiments, the holder 34 is configured to draw blood such that the sharp proximal end 78 of the cannula 22 and the elastomeric sleeve 46 extend through the distal end of the blood collection tube 50. It may be configured to be coupled to the tube 50. Some embodiments of the blood collection device 12 may be used independently or in conjunction with an existing catheter system or blood collection set 102 . As shown in FIG. 4A , some embodiments of blood collection device 12 may be attached to blood collection system 10 including, for example, a peripheral IV catheter (“PIVC”). As shown in FIG. 4B , some embodiments of holder 34 may be configured to couple to needleless adapter 54 . As shown in FIG. 4C , some embodiments of holder 34 may be configured to couple to the proximal end of catheter adapter 104 .

5 and 6 , in some embodiments, holder 34 may include a protrusion 52 extending along longitudinal axis 30 from proximal end 36 of holder 34 . Some embodiments of protrusion 52 may include at least a portion of channel 40 . In some embodiments, shaft 42 of cannula 22 may be retained by channel 40 to support proximal end 24 of cannula 22 as protrusion 52 extends into elastomeric sleeve 46. can

In some embodiments, protrusion 52 may include one or more priming openings 48 . As shown in the enlarged view of FIG. 5 , for example, gap opening 53 may extend through protrusion 52 along longitudinal axis 30 . In this way, some embodiments of protrusion 52 may allow cannula 22 to be manipulated relative to protrusion 52 by providing a gap space between the outer surface of cannula 22 and the inner surface of protrusion 52 . there is.

As shown in FIG. 6 , some embodiments of cannula 22 may include a slot 32 that allows unobstructed visualization of small amounts of blood through cannula 22 . In some embodiments, visualization of such blood flashbacks may provide vein identification.

Some embodiments of holder 34 may include a visual check window 44 configured to align with slot 32 when holder 34 supports shaft 42 of cannula 22 . Some embodiments of the visual inspection window 44 may include an opening or slot disposed in the holder 34 and positioned to correspond to the slot 32 of the cannula 22 . In some embodiments, visual check window 44 may include an opening at least as large and shaped as slot 32 so that blood flashback may be visualized therethrough. In some embodiments, the visual check window 44 may include a graduated dimension that increases from the inner surface of the holder 34 adjacent the slot 32 toward the outer surface of the holder 34 . Some embodiments of the visual check window 44 may include a circular, rectangular, polygonal or other suitable shape and/or cross-sectional shape.

7 and 8 , in some embodiments, the protrusion 52 may include one or more priming openings 48 between the protrusion 52 and the proximal end 36 of the holder 34 . In some embodiments, the priming opening 48 may include a priming slot 55 disposed transversely to the longitudinal axis 30 along the proximal end 36 of the holder 34 . In some embodiments, priming aperture 48 further comprises a gap aperture 53 integrated through holder 34 and protrusion 52 along longitudinal axis 30 and between channel 40 and cannula 22 . can do.

Some embodiments of priming slot 55 may be selectively blocked by elastomeric sleeve 46 upon application of an external force, such as that exerted by blood collection tube 50 when attached to the proximal end of holder 34. there is. In some embodiments, the elastomeric sleeve 46 may be deformed to passively block the priming slot 55 or other priming opening 48 . In some embodiments, deformation of the elastomeric sleeve 46 may cause the proximal end 24 of the cannula 22 to extend through the proximal end of the elastomeric sleeve 46 .

9a-b, 10a-b, 11a-b, 12a-b and 1a-b show various embodiments of a priming opening 48 incorporated in various embodiments of a holder 34 and protrusion 52. are doing For example, as shown in FIGS. 9A and 9B , some embodiments of priming opening 48 will include one or more priming slots 55 integral to the outer surface of proximal end 36 of holder 34. can Some embodiments may include a single priming slot 55 disposed transverse to the longitudinal axis 30, as shown in FIG. 9A. Some embodiments may include two priming slots 55 disposed opposite to each other about the longitudinal axis 30, as shown in FIG. 9B. In some embodiments, protrusion 52 may be coupled or integrated into proximal end 36 of holder 34 to overlap one or more priming slots 55 . In some embodiments, channel 40 may extend through the center of protrusion 52 and holder 34 to support cannula 22 therein.

As shown in FIGS. 10A and 10B , some embodiments of protrusion 52 may include a priming opening 48 integrated into the sidewall such that channel 40 is open on at least one side. In some embodiments, priming opening 48 may further be incorporated into at least a portion of proximal end 36 of holder 34 .

As shown in FIGS. 11A and 11B , some embodiments of the holder 34 may include an elongate portion 108 having a protrusion 52 extending along the longitudinal axis 30 . In some embodiments, the elongate portion 108 may include one or more threads 106 or other suitable coupling mechanism. Some embodiments of elongate portion 108 may include a priming opening 48 . As shown, the priming opening 48 may include a single prime hole 110 integrated into the elongate portion 108 near the interface between the proximal end of the elongated portion 108 and the distal end of the elastomeric sleeve 46. can In another embodiment, as shown in FIGS. 12A and 12B , the elongated portion 108 may include a plurality of prime holes 110 and/or threads 106 thereof integrated into a surface.

13A and 13B , in some embodiments, the priming opening 48 includes a priming slot 55 incorporated into the protrusion 52 and extending into at least a portion of the elongate portion 108 and/or threaded portion 106. can include In any case, the priming slot 55 can be blocked and/or sealed by the elastomeric sleeve 46 upon application of an external force that deforms the elastomeric sleeve 46 .

14 and 15 , some embodiments of blood collection device 12 may include a body 64 having a distal end 66 , a proximal end 68 and a longitudinal axis 70 extending therebetween. there is. In some embodiments, an outer surface of body 64 may provide a contact interface 56 for a user to grasp. Some embodiments of contact interface 56 may include ridges, bumps, meshes, or other suitable textures or structures to provide a firm grip. In some embodiments, septum 72 may be disposed within body 64 .

In some embodiments, cannula 22 having a distal end 76 and a pointed proximal end 78 may extend through septum 72 . In some embodiments, cannula 22 may include steel cannula 22 or other suitable material. In some embodiments, elastomeric sleeve 46 may be coupled to body 64 to cover sharp proximal end 78 of cannula 22 . Some embodiments of the elastomeric sleeve 46 may be liquid impermeable and biocompatible. For example, in some embodiments, elastomeric sleeve 46 may include rubber or other suitable material. In some embodiments, the elastomeric sleeve 46 may automatically seal the air priming path in response to the blood collection tube 50 being coupled to the body 64 .

In some embodiments, blood collection device 12 may be connected to a port of adapter 14 . As shown in FIG. 14 , for example, some embodiments of adapter 14 may include a first proximal port 60 , a second proximal port 62 , and a distal port 58 . In some embodiments, blood collection device 12 may be coupled to first proximal port 60 via needleless adapter 54 , such as a Luer adapter. For example, as shown, some embodiments of blood collection device 12 may include a male luer adapter 84 configured to connect to first proximal port 60 . In some embodiments, the distal end 66 of the body 64 of the blood collection device 12 includes a male luer adapter 84 and the cannula 22 extends through the proximal end 68 of the body 64. can In some embodiments, the proximal end 68 of the body 64 may be configured to couple to a blood collection tube 50 such as a VACUTAINER™. In some embodiments, the sharp proximal end 78 of the cannula 22 may extend into the blood collection tube 50 to provide a pathway for blood collection.

In some embodiments, to prevent blood from contaminating first proximal port 60 , the air priming path of blood collection device 12 may be separate from the blood collection path. In some embodiments, as shown in FIGS. 16A and 16B , for example, a seal ring 88 may be disposed within the first proximal port 60 and a cannula 22 extending therethrough. Some embodiments of seal ring 88, such as that shown in FIG. 16A, may be disposed adjacent septum 72. Other embodiments of a seal ring 88 such as that shown in FIG. 16B may be disposed at the distal end 66 of the first proximal port 60 . In some embodiments, seal ring 88 may isolate blood within cannula 22 and prevent blood from contaminating the internal cavity of adapter 14 .

In some embodiments, the body 64 may include at least a portion of an air priming path for priming air from the adapter 14 . For example, some embodiments of the body 64 may include an air tube 80 and an air film 82 . In some embodiments, air tube 80 may extend through diaphragm 72 . In some embodiments, air tube 80 may pass through diaphragm 72 . Some embodiments of septum 72 may self-seal upon withdrawal of air tube 80 and/or cannula 22 . In some embodiments, body 64 and septum 72 of blood collection device 12 may be used as needleless adapter 54 when withdrawing air tube 80 and cannula 22 .

Some embodiments of the air film 82 may be disposed proximate to the air tube 80 . In some embodiments, body 64 may include an extension 86 between elastomeric sleeve 46 and septum 72 configured to be supported by a user. Some embodiments of air film 82 may be disposed within extension 86 . In some embodiments, the air priming path including air tube 80 and air film 82 may be automatically sealed as blood collection tube 50 is coupled to body 64 .

17A and 17B , in some embodiments, at least a portion of the blood collection device 12 may be disposable, while the remaining components of the blood collection device 12 may be reusable, thereby improving procedural efficiency and future blood collection procedures. can improve 17A and 17B, in some embodiments, cannula 22, body 64, air tube 80 and air film 82 and elastomeric sleeve 46 may be placed for implantation or indwelling. On the other hand, the seal ring 88, the male luer adapter 84, and the septum 72 remain coupled to the first proximal port 60 of the adapter 14 and can be reused. As previously discussed, seal ring 88 may be placed on either distal end 66 or proximal end 68 of body 64 depending on its use and/or manufacturing process.

Referring to FIGS. 18A and 18B , in some embodiments, an air pipe 80 may include a plurality of channels 90 . In some embodiments, some of the channels 90 may be used for blood sampling and other channels 90 may be used for air priming. For example, as shown in FIG. 18B , in some embodiments a first channel 92 may be used for blood collection and a second channel 94 may be used for air priming. In some embodiments, the second channel 94 is sealed at both distal tips and may include one or more openings for providing air priming.

Referring to FIGS. 19A and 19B , some embodiments of the air priming path may include a porous air rod 96 instead of the air tube 80 and the air film 82 . Some embodiments of the air rod 96 may include a porous material that is breathable and impervious to liquids. In this way, some embodiments of the air rod 96 may be configured to allow free flow of air while preventing liquid from penetrating the air rod 96 .

In some embodiments, air rod 96 may be integrated with body 64 of blood collection device 12 . In other embodiments, air rod 96 may be detached from body 64 of blood collection device 12 and/or after performing a blood collection procedure.

All examples and conditional language cited herein are for pedagogical purposes to aid the reader in understanding the invention and the concepts that the inventor contributed to advance the art, and interpretation is not limited to such specifically cited examples and conditions. It should be. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions and modifications may be made without departing from the spirit and scope of the present invention.

Claims (20)

A blood collection device for priming a blood flow pathway, comprising:
a cannula comprising a proximal end, a distal end and a lumen extending along a longitudinal axis therebetween and including a slot through which a user can visualize the blood flow path through the cannula;
a holder comprising a proximal end, a distal end and a channel extending therebetween, wherein the channel is configured to align with a longitudinal axis to maintain an axis of the cannula, the holder comprising a visual check window corresponding to a slot of the cannula; and
A blood collection device comprising an elastomeric sleeve coupled to the holder and surrounding a proximal end of a cannula, wherein a priming aperture is disposed between the elastomeric sleeve and the holder to prime a blood flow path. The blood collection device according to claim 1, wherein the priming opening is automatically sealed in response to the blood collection tube coupled to the holder. The blood sampling device according to claim 2, wherein the elastomeric sleeve automatically seals the priming opening. 3. The blood collection device of claim 2, wherein the holder is configured to couple to the blood collection tube such that the proximal end of the cannula and the elastomeric sleeve extend through the distal end of the blood collection tube. The blood collection device of claim 1 , wherein the holder further comprises a protrusion extending along the longitudinal axis from a proximal end of the holder. The blood sampling device according to claim 5, wherein the protrusion includes at least a portion of the channel. 6. The blood sampling device according to claim 5, wherein the protrusion includes the priming opening. The blood sampling device according to claim 1, wherein the holder is configured to be coupled to the needleless connector. The blood collection device of claim 1 , wherein the holder includes a contact interface for physical manipulation of the cannula. blood collection system,
an adapter comprising a distal port, a first proximal port and a second proximal port;
a blood collection device coupled to the first proximal port;
The blood collection device,
a body comprising a distal end, a proximal end and a longitudinal axis extending therebetween;
a diaphragm disposed within the body;
a cannula comprising a distal end and a pointed proximal end and extending through the septum;
an elastomeric sleeve coupled to the body and covering the sharp proximal end of the cannula;
an air pipe extending through the diaphragm; and
an air film disposed proximate to the air pipe;
The blood collection system of claim 1 , wherein the air priming path includes the air pipe and the air membrane, and the blood collection path separated from the air priming path includes the cannula. 11. The blood collection system of claim 10, wherein the distal end of the body includes a male luer adapter and the cannula extends through the proximal end of the body. 11. The blood collection system according to claim 10, wherein the main body includes an extension between the diaphragm and an elastomeric sleeve configured to be supported by a user, and wherein the air film is disposed within the extension. 11. The blood collection system of claim 10, wherein the elastomeric sleeve automatically seals the air priming path in response to coupling of the blood collection tube to the body. 11. The blood collection system of claim 10, further comprising a seal ring disposed within the first proximal port through which the cannula extends. 15. The blood collection system of claim 14, wherein the seal ring is disposed at a distal end of the first proximal port. 15. The blood collection system of claim 14, wherein the seal ring is disposed adjacent to the septum. 11. The blood collection system according to claim 10, wherein the air pipe includes a plurality of channels. The blood collection system according to claim 10, wherein the blood collection path includes a first channel of the plurality of channels, and the air priming path includes a second channel of the plurality of channels. The blood collection system according to claim 10, wherein the air priming path includes an air rod to replace the air pipe and the air film, and the air rod includes a porous material for passing air and blocking liquid. The blood collection system according to claim 19, wherein the air rod is integrated with the main body.

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